Cranberry and UTIs: Europe Regulatory Profile

The search for substances that are effective at treating UTIs is a pertinent one, as more bacterial strains become resistant to anti-biotic treatment. Prior to introduction of the EU Nutrition and Health Claim regulations (NHCR) 2006, Cranberry juice and food supplements often carried claims about preventing or treating UTIs. However The European Food Safety Authority (EFSA) concluded under the NHCR that the evidence submitted to them so far is insufficient for any UTI health claims to be made on Cranberry. Commercially there are two main types of Cranberry: American (large) cranberry (Vaccinium macrocarpon Ait.) Small Cranberry (Vaccinium oxycoccos L.). The largest producers are North America and business is going well, thanks to new export markets such as China where Cranberry has become a popular health food. The Key constituents of commercial interest include: Anthocyanin, Proanthocyanidin, Ascorbic acid (vitamin C), Melatonin and Serotonin. A Cochrane review concluded there was some evidence to show cranberry prevented recurrent UTI infections in women, however overall they concluded that a highnumber of participants dropped out of cranberry juice studies and that dried cranberry powder studies had no standardised quantity of active ingredient (Proanthocyanidin) therefor they could not conclude that cranberry was effective for UTIs. We really must have a talk with plants about standardising themselves (forthcoming blog). The natural Standard, an evidence based CAM research database, gives Cranberry a C grading for UTI infections, which means they deem the evidence unclear or conflicted due to factors like differing conclusions from multiple control trails.

In the US FDA deems cranberry powder in capsule form a ‘dietary supplement’ and it is possible to say on the label ‘helps maintain the health of the urinary tract’ However if the label stated ‘helps prevent or treat UTIs’ the product would be regulated as a drug, but in Europe the picture is more restrictive. Cranberry is ok to use in food supplements in Europe. However numerous claim submissions to EFSA on the ability of cranberry juice or powder to maintain, protect or inhibit the UTIs or maintain the heart, blood vessels, stomach, gums, immune system or any protective anti-oxidant properties have ALL been rejected.

The medical device route has helped some companies circumvent the restrictive EU regulatory market. Dutch firm, Medical Brands and Decas Botanical Synergies (Carver, MA) gained Class IIa medical device status in 2012 for Cranberry-Active Bladder Capsules, intended to treat or prevent UTIs. They are now using Cranberry-Active™ in their I SAY: UTI products and it is doing very well, largely due the fact it is one of the few companies in the EU that can make Cranberry based UTI claims. However French firm, Arkopharma have recently suffered the blow of having their cranberry UTI product, Cis-Control stripped of its medical device status. French authorities reviewed Cis-Control’s technical dossier and found it lacking in robust enough evidence. They now have to sell Cis-Control as a food supplement minus any claims. Medical brands put €3 million and 7 years of research into their cranberry product and maintain that it is effective due to a combination of substances in Cranberry-Active™. Avena Consultants next post will be ‘Botanicals as Medical Devices a viable option?’ For advice on the legal status of any substance in Europe, just ask.